1. Field of the Invention
The present invention relates to Radiation Therapy. More particularly, the present invention relates to Intraoperative Radiation Therapy.
2. General Background of the Invention
Intraoperative Radiation Therapy (IORT) is the use of radiation to treat cancers during surgery. Two types of treatment exist: X-ray and Electron Beam. While there are numerous effective uses of both treatments, there are few that are considered either economically competitive or medically superior to alternative treatments. With the use of electron beam linear accelerators, teams around the world have proven that Intraoperative Electron Radiation Therapy (IOERT) is equivalent to External Beam Radiation Therapy or Intensity Modulated Radiation Therapy for early breast cancer. Moreover, it is believed to be six times more cost efficient, reducing the cost of treating certain cancers from $30,000 to $5,000 (anticipated Medicare reimbursement rate in 2014).
There are two reasons IOERT technology has not been adopted in the United States. First, the US Government does not reimburse the treatment through Medicare, preventing market participants from profiting from ownership. Second, the inability to share machines between hospitals limits the number of market participants to those that have the critical mass of breast cancer cases to provide IOERT services profitably.
Even when Medicare does begin reimbursement for IOERT, the number of cases required to provide IOERT services profitably, limits the market to extremely large hospitals since machines cannot easily be shared. Transportation allows hospitals to share the capital cost, allowing for even small hospitals to provide IOERT services profitably.
Medicare has not reimbursed the IOERT market for many reasons, but from a practical point of view reimbursement would cause a misallocation of capital since the current class of IOERT machines are unable to be transported between hospitals efficiently. Although they claim to be transportable between hospitals, the machines must be calibrated for at least three energies of the machine to ensure proper function according to some studies. In the end, this amounts to three energies and multiple collimators to create different treatment fields. Prior to use of the machine on a patient one must test at least the energy being delivered for surgery and the ability to change the beam to one energy above and below the prescribed dose. This type of testing is called calibration. Calibration must be done every time the machine is moved between hospitals to ensure it is working in the way intended.
One can find boluses for use in radiation therapy at the following website: http://www.dotdecimal.com/products/ect. The following patent references are incorporated herein by reference: U.S. Pat. No. 8,094,779, U.S. Pat. No. 8,073,105, U.S. Pat. No. 5,037,374, U.S. Pat. No. 6,381,304, U.S. Pat. No. 7,834,336, U.S. Pat. No. 8,106,371.